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Last Updated: December 3, 2021

DrugPatentWatch Database Preview

Cysteamine bitartrate - Generic Drug Details

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What are the generic sources for cysteamine bitartrate and what is the scope of patent protection?

Cysteamine bitartrate is the generic ingredient in two branded drugs marketed by Horizon, Mylan, and Horizon Pharma Usa, and is included in three NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cysteamine bitartrate has fifty-six patent family members in thirty-three countries.

There are six drug master file entries for cysteamine bitartrate. One supplier is listed for this compound.

Recent Clinical Trials for cysteamine bitartrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Children's Hospital Medical Center, CincinnatiPhase 1
Horizon Pharma USA, Inc.Phase 2
Raptor Pharmaceuticals Inc.Phase 2

See all cysteamine bitartrate clinical trials

Pharmacology for cysteamine bitartrate
Paragraph IV (Patent) Challenges for CYSTEAMINE BITARTRATE
Tradename Dosage Ingredient NDA Submissiondate
PROCYSBI CAPSULE, DELAYED RELEASE;ORAL cysteamine bitartrate 203389 2020-05-11

US Patents and Regulatory Information for cysteamine bitartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon Pharma Usa PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Horizon Pharma Usa PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for cysteamine bitartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1919458 300649 Netherlands ⤷  Try it Free PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
1919458 C300649 Netherlands ⤷  Try it Free PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130906
1919458 C 2014 012 Romania ⤷  Try it Free PRODUCT NAME: CISTEAMINABITARTRAT; NATIONAL AUTHORISATION NUMBER: EU/1/13/861; DATE OF NATIONAL AUTHORISATION: 20130906; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/861; DATE OF FIRST AUTHORISATION IN EEA: 20130906
1919458 SPC/GB14/019 United Kingdom ⤷  Try it Free PRODUCT NAME: CYSTEAMINE; REGISTERED: UK EU/1/13/861 20130910
1919458 194 50001-2014 Slovakia ⤷  Try it Free PRODUCT NAME: MERKAPTAMIN; FIRST REGISTRATION: EU/1/13/861, 20130906
1919458 19/2014 Austria ⤷  Try it Free PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
Moodys
Medtronic
Merck
Boehringer Ingelheim

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